1. Field of the Invention
The present invention relates generally to vaccines that include an adjuvant, and to adjuvants alone. In particular, the invention relates to adjuvants derived or obtained at least in part from biological tissues, such as extracellular matrix material. In particular, the extracellular matrix material may be further described as comprising a heterologous acellular collagenous preparation, particularly a mammalian tissue preparation having these characteristics. The invention also relates to the field of methods for immunizing an animal against diseases associated with infectious pathogens, and infections by said pathogens, or toxins using a vaccine preparation that comprises includes an adjuvant comprising a heterologous acellular tissue preparation. The invention also relates to the field of methods for preparing adjuvants comprising a heterologous acellular tissue preparation, as a method for preparing an adjuvant comprising a heterologous acellular tissue preparation from a mammalian tissue so as to have these characterisitics, for use as a part of a vaccine to immunize an animal against diseases associated with an infectious agent, and in particular, against tetanus, as a vaccine for the treatment and/or prevention of tetanus, is provided.
2. Related Art
Aluminum hydroxide and aluminum phosphate (collectively referred to as alum) are routinely used as adjuvants in human and veterinary vaccines (1). The efficacy of alum in increasing antibody responses to diphtheria and tetanus toxins is well established (2) and Hepatitis B virus antigen vaccine has been adjuvinated with alum (3). While the usefulness of alum is well established for some applications, it has limitations. For example, alum is a poor inducer of Th1 cellular immune responses and stimulates the production of antibodies, which is consistent with Th2 cellular immune response (4-6). Unfortunately, a Th2 based immune response is not likely to offer optimal protection against several important infectious diseases, including tuberculosis (TB), human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Alum is poorly effective for influenza vaccination and inconsistently elicits a cell mediated immune response. The antibodies elicited by alum-adjuvinated antigens are mainly of the IgG1 isotope in the mouse, which may be optimal for protection by some vaccinal agents.
Tetanus is an important human and animal disease characterized by painful, uncontrolled muscle spasms, and death due to paralysis of the respiratory muscles. This disease is associated with infection by Clostridium tetani and prophylactic vaccination is common. Vaccines of many types, including tetanus vaccines, typically use alum as an adjuvant.
A need continues to exist in the medical arts for alternative vaccine adjuvant materials that may be used to enhance and/or improve existing clinical vaccine preparations for treatment and prophylaxis of disease associated with infectious agents and toxins. Adjuvant alternatives having superior characteristics to alum and other standard adjuvant materials are presented as part of the present invention, and present improved vaccines for many infectious agents and toxins, including tetanus.